# K011948: Hoffman II Hybrid Ring Clamp

- Pathway: 510(k) (Special)
- Applicant: Howmedica Osteonics Corp.
- Decided: Jul 13, 2001 after 22 days
- Product code: LXT (Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K000197: Cortek Cystoscope, Cortek Endoscopy, Inc. (2000). Our OCR of the scanned summary read K000197, FDA’s number for Cortek Cystoscope (Cortek Endoscopy, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Hoffmann® II Hybrid Ring Clamp”. Kept off the family tree. Summary page 1.

## Indications for use
The Hoffmann® II Hybrid External Fixation System is intended to be used in conjunction with the Apex™ Half Pins of the Hoffmann® External Fixation System and Kirschner Wires of the Monticelli Spinelli™ External Fixation System, and may be used as a Hybrid External Fixation System with the components of the Hoffmann® II External Fixation System and the Monotube® TRIAX"™ External Fixation System. This device is used to provide stabilization of open and/or unstable fractures and where soft tissue injury may preclude the use of other fracture treatments such as IM rods, casts, or other means of internal fixation. The indications for use of metallic external fixation devices include: • Bone fracture fixation • Osteotomy • Arthrodesis • Correction of deformity • Revision procedure where other treatments or devices have been unsuccessful • Bone reconstruction procedures

Source page: https://510kreport.com/device/K011948
Methodology: https://510kreport.com/methodology